MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC DIRECT LATERAL INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 2940075

Device Problem Component Missing (2306)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

For: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional via field contact regarding a patient with a pre-operative diagnosis of spinal canal stenosis, undergoing an olif procedure for a spinal therapy.It was reported that, from the beginning, there was no socket set screw on the connecting part between the reported rongeur handle and the shaft.Olif was performed at l2/5.The reported product was not used because the event was noticed before the reported product was used.The doctor did not find any objects like the screw around, so the procedure was continued and finally the image was checked and confirmed that there were no foreign objects remaining in the patient¿s body.The instrument had been prepared with being put in a hospital basket.There were no patient symptoms or complications as a result of this event.There was a delay of less than 60 mins in the overall procedure time.Additional comments about the event stated that, as for the reason of this event, there were doubts about the process from delivery to the hospital to washing, but it was strictly pointed out for quality checks such as screw loosening and dropping due to vibration required for routine cleaning and carrying-in right from the start.

Event Description

Information was received from a healthcare professional via field contact regarding a patient with a pre-operative diagnosis of spinal canal stenosis, undergoing an olif procedure for a spinal therapy.It was reported that, from the beginning, there was no socket set screw on the connecting part between the reported rongeur handle and the shaft.Olif was performed at l2/5.The reported product was not used because the event was noticed before the reported product was used.The doctor did not find any objects like the screw around, so the procedure was continued and finally the image was checked and confirmed that there were no foreign objects remaining in the patient¿s body.The instrument had been prepared with being put in a hospital basket.There were no patient symptoms or complications as a result of this event.There was a delay of less than 60 mins in the overall procedure time.Additional comments about the event stated that, as for the reason of this event, there were doubts about the process from delivery to the hospital to washing, but it was strictly pointed out for quality checks such as screw loosening and dropping due to vibration required for routine cleaning and carrying-in right from the start.Additional information received.It was reported that this was an out-of-box issue.The product has not been used in the operation at all.Levels implanted: l2-5.

Manufacturer Narrative

H3: product analysis: visual and functional inspection revealed the screw on the upper shaft is missing.The instrument will not function correctly without the screw.Unable to determine root cause of missing screw.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DIRECT LATERAL INSTRUMENTS
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10263228
• MDR Text Key: 199740341
• Report Number: 1030489-2020-00879
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00613994120120
• UDI-Public: 00613994120120
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2940075
• Device Catalogue Number: 2940075
• Device Lot Number: GZ15D014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1